Richard John Gillis

**** *** ***** **.

Bozeman, MT 59715

406-***-****

abqeye@r.postjobfree.com

EXPERIENCE:

President Integrity Device Auditing and Consulting, LLC - 2010

o Sterilization consulting

o Validation consulting

o Scientific data review for 510k submission

Scientific Advisor, Board of Directors, M-Vac Systems Inc. 2009 to 2010

o production facility auditing

o GMP compliance advisement

o scientific data review for product submission

Production Manager, SGM Biotech, Inc. 2004 to 2008

o Daily oversight and communication to upper management regarding production

status in the manufacturing and QC labs

o Writing, reviewing, and maintaining SOPs

o Collection and review of environmental monitoring of production equipment

and RO water system

o Setting and maintaining appropriate EM alert levels for a non-sterile class I

medical device

o Writing and directing investigative reports and CAPAs

o Daily review of biological indicator data including spore strips, liquid carriers,

inoculated product

Graduate Research Assistant, University of Rochester 1999-2004

o Antibiotic sensitivity assessment of biofilms via MIC and MBC methods

o RNA collection, isolation, and purification of bacterial biofilms

o Gene Chip analysis

o Fermentation

o Disinfection efficacy using hard surface carrier test

o Microbial identification via API strips, 16S rRNA, PFLA, MIDI

Industrial Engineer Lead, 777 Boeing Commercial Airplane Group, Inc. - 1996 to 1999

o Supervisor of industrial engineering group

o Implementation of lean manufacturing initiatives

o Coordination of change control

o Manpower assessment to support production

o Implementation of BAAN/ERP software

Validation Specialist, JR Gillis Associates - 1988 to 1996

o Development of validation programs for sterility assurance

o Writing and reviewing IQ, OQ, PQ documentation

o Bioburden assessment of non-sterile product

o LAL testing of non-sterile product

o Validation of steam, ethylene oxide, dry heat sterilizers

EDUCATION:

Ph.D. Microbiology, University of Rochester, Rochester, NY, USA

M.Sc. Microbiology, Montana State University, Bozeman, MT, USA

B.Sc. Biology, Montana State University, Bozeman, MT, USA

PROFESSIONAL AFFILIATIONS:

Member, American Society for Quality (ASQ)

Member, Society for Quality Assurance (SQA)

Member, Parenteral Drug Association (PDA)

Member, Association for the Advancement of Medical Instrumentation (AAMI)

TRAINING AND CERTIFICATIONS:

ASQ CBA Auditor training

PUBLICATIONS AND PRESENTATIONS:

Gillis RJ, White KG, Choi KH, Wagner VE, Schweizer HP, Iglewski BH. Molecular basis of azithromycin-

resistant Pseudomonas aeruginosa biofilms. Antimicrob Agents Chemother. Sept 2005; 49(9):3858-67.

Gillis RJ, Iglewski BH. Azithromycin retards Pseudomonas aeruginosa biofilm formation. J Clinical Microbiol.

Dec 2004; 42(12):5842-5.

Wagner VE, Gillis RJ, Iglewski BH. Transcriptome analysis of quorum-sensing regulation and virulence factor

expression in Pseudomonas aeruginosa. Vaccine Dec 2004;22 supple 1:S15-20.

DeKievit TR, Parkins MD, Gillis RJ, Srikumar R, Ceri H, Poole K, Iglewski BH, Storey DG. Multidrug efflux

pumps: expression patterns and contribution to antibiotic resistance in Pseudomonas aeruginosa biofilms.

Antimicrob Agents Chemother. June 2001; 45(6):1761-70.

DeKievit TR, Gillis R, Marx S, Brown C, Iglewski BH. Quorum-sensing genes in Pseudomonas aeruginosa

biofilms: their role and expression patterns. Appl. Environ. Microbiol. Apr 2001;67(4):1865-73.

Geesey GG, Gillis RJ, Zhang HJ, Bremer PJ. Influence of surface features on microbial colonization and

susceptibility to corrosion of stainless steels used in the food processing industry. Proc AIWC Feb

1996;43(3):1053-67.

Gillis, RJ, Gillis JR. Microbials: A comparative study of bacterial attachment to high-purity water system

surfaces. Ultrapure Water. Sept 1996;13(6):27-36.

Geesey GG, Gillis RJ, Avci R, Daly D, Hamilton M, Shope P, Harkin G. Influence of surface features on

bacterial colonization and subsequent substratum chemical changes of 316L stainless steel. Corrosion Sci.

Jan 1996; 38(1):73-95.

Hamilton MA, Johnson KR, Camper AK, Stoodley P, Harkin GJ, Gillis RJ, Shope PA. Analysis of bacterial

spatial patterns at the initial stage of biofilm formation. Biometrics. 1995; 37(4);393-408.

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